Cleared Special

K152453 - LENSAR Laser System - fs 3D (LLS-fs 3D)

K152453 is an FDA 510(k) clearance for LENSAR Laser System - fs 3D (LLS-fs 3D), manufactured by Lensar, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Special 510(k) pathway after a 48-day FDA review.

K152453 · Lensar, Inc. · Ophthalmic device
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Oct 2015
Decision
48d
Days
Class 2
Risk

K152453 is an FDA 510(k) clearance for the LENSAR Laser System - fs 3D (LLS-fs 3D). Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on October 15, 2015 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lensar, Inc. devices

FDA 510(k) Submission Details - K152453

510(k) Number K152453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date October 15, 2015
Days to Decision 48 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

OOE Device Classification - Class 2, Special Controls

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K152453.
LenSX Laser System
K161288 · Alcon Laboratories, Inc. · Nov 2016
Catalys Precision Laser System
K161455 · Optimedica Corporation · Sep 2016
FEMTO LDV Z8 Surgical Laser
K150323 · Sie Ag,Surgical Instrument Engineering · Oct 2015
VICTUS Femtosecond Laser Platform
K151161 · Technolas Perfect Vision GmbH · Jun 2015
LENSAR Laser System - fs 3D
K143010 · Lensar, Inc. · Mar 2015
VICTUS FEMTOSECOND LASER PLATFORM
K141379 · Technolas Perfect Vision GmbH · Jan 2015